BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM CRAYOLA FLOSSER

    MDR report key: 13047902 · Received December 20, 2021

    Report

    Report Number
    0001413787-2021-00018
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    May 14, 2019
    Report Date
    May 14, 2019
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    JES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    WE RECENTLY STARTED USING THE GUM CRAYOLA KIDS FLOSSERS AND TONIGHT, MY (B)(6) SOMEHOW GOT ONE OF THE FLOSSERS COMPLETELY INSIDE HER MOUTH AND INTO HER THROAT, AND SHE WAS CHOKING ON IT. LUCKILY SHE COUGHED IT OUT AND IT CAME OUT OF HER THROAT/MOUTH WHEN SHE PUKED FROM CHOCKING ON IT AND SHE IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940880 GUM CRAYOLA FLOSSER FLOSSER JES SUNSTAR AMERICAS, INC. 897RZ

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Other